A Phase 1/2 interventional study of JAB-3312 and Binimetinib in Solid Tumor and NSCLC, sponsored by Allist Pharmaceuticals, Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Allist Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment
To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.
To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 58 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Allist Pharmaceuticals, Inc. is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose escalation
Drug: JAB-3312 · Drug: Pembrolizumab
Dose escalation
Drug: JAB-3312 · Drug: Binimetinib
Dose expansion
Drug: JAB-3312 · Drug: Pembrolizumab
Dose expansion
Drug: JAB-3312 · Drug: Binimetinib
Dose escalation
Drug: JAB-3312 · Drug: Sotorasib
Dose escalation
Drug: JAB-3312 · Drug: Osimertinib
Dose expansion
Drug: JAB-3312 · Drug: Sotorasib
Dose expansion
Drug: JAB-3312 · Drug: Osimertinib
JAB-3312 will be administered orally, variable dose.
Binimetinib will be administered orally.
Pembrolizumab will be administered as an intravenous infusion.
Sotorasib will be administered orally.
Osimertinib will be administered orally.
Number of participants with dose limiting toxicities
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)
Time frame: 24 months
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)
Time frame: 24 months
Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)
Time frame: 24 months
Duration of response (DCR)
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)
Time frame: 24 months
Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)
Time frame: 24 months
Overall survival (OS)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)
Time frame: 24 months
Number of participants with adverse events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)
Time frame: 24 months
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)
Time frame: 24 months
Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose escalation phase)
Time frame: 24 months
Duration of response (DCR)
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)
Time frame: 24 months
Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose escalation phase)
Time frame: 24 months
Overall survival (OS)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)
Time frame: 24 months
Plasma concentration (Cmax)
Highest observed plasma concentration of JAB-3312(dose escalation phase)
Time frame: 24 months
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of JAB-3312(dose escalation phase)
Time frame: 24 months
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of JAB-3312(dose escalation phase)
Time frame: 24 months
Number of participants with adverse events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose expansion phase)
Time frame: 24 months
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Allist Pharmaceuticals, Inc.